Assessing the Safety of Glucose-Lowering Drugs — A New Focus for the FDA
William H Chong, Lisa B. Yanoff, Eugenio Andraca‐Carrera, Mary Thanh Hai
Abstract
The FDA is moving away from a narrow focus on evaluating the cardiovascular safety of drugs for glycemic control and recommending that such drugs be studied in broad, representative populations of patients to permit a meaningful assessment of various potential risks.
Topics & Concepts
MedicineGlycemicIntensive care medicineFocus (optics)Drug approvalPharmacologyPatient safetyDrugRisk analysis (engineering)Diabetes mellitusHealth careEndocrinologyEconomicsEconomic growthPhysicsOpticsDiabetes Treatment and ManagementDiabetes Management and ResearchMetabolism, Diabetes, and Cancer